GDP Forum
Im Auftrag der ECA Academy

24/25 June 2020

Barcelona, Spain

Seminar Nr. 17226

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Sprecher

Dr Michael Aigner, University Erlangen
Cheryl Chia, Lotus Phoenix Consulting
Dr Martin Egger, Pharmaserv Logistics
Prof René Geyeregger, St. Anna Children’s Cancer Research Institute
Dr Christian Grote-Westrick, B. Braun Avitum AG
Jochen Heinzel, F. Hoffmann-La Roche
Dr Afshin Hosseiny, European GDP Association
Saddam Huq, GlaxoSmithKline
Saskia Killer, Oncotec Pharma Produktion
Sue Mann, Sue Mann Consultancy
Axel Radke, Trust Expertenservice
Dr Laura Ribeiro, OCP Portugal
Dr Torsten Schmidt-Bader, moveproTEC
Emil Schwan, Swedish Medical Products Agency
Maria Sekamwa, Surgipharm
Gundula Warnecke, Oncotec Pharma Produktion

Zielsetzung

The aim of this conference is to inform about recent experiences made in the implementation of the EU GDP Guidelines. Challenges and possible solutions will be discussed and examples will demonstrate how the requirements can be put into practice.

Hintergrund

It is of key importance that medicinal products are not only made to a high quality in accordance with Good Manufacturing Practice (GMP), but that the quality and integrity of these products are maintained through the entire supply chain to the patient. This is where Good Distribution Practice (GDP) comes into Play.

In the last few years the world of GDP has changed in scope and complexity and continues to evolve to meet new challenges with the continued aim of safeguarding public health. The Falsified Medicines Directive (2011/62/EU) was transposed into the laws and regulations of the EU Member States alongside the introduction of revised EU guidelines on Good Distribution Practice. Many other countries followed adopting these Guidelines or implementing very similar approaches.

Zielgruppe

All personnel involved in pharmaceutical storage, transportation, cold chain and distribution activities and the control of those activities.

Question and Answers Session

You will be able to send in GDP related questions before the conference. Additionally, questions can be posted on question cards during the conference.

Answers will be given by the expert speakers in a dedicated session and published in the members are of the GDP Association’s website (www.good-distribution-practice-group.org).

Programm

Performance beyond Compliance

Benchmarks with sense
When is a system or process robust?
Easily understandable key figures
Case studies

Brexit Implications

Import/ export issues
Drug shortage challenges
Falsification
Serialisation
Co-operation of the agencies

GDP Challenges in Africa

Background
Evolution of GDP over the years
Problems involved
Steps taken to improve

Customer Master Data

Definitions
Parties involved
Responsibilities and RP oversight
Managing Customer Master Data
Lifecycle Management

3 parallel Workshops:
1. Risk Management in GDP Warehousing

Challenges and possible solutions
Examples

2. When things go wrong – what can happen in the real World

Experiences made in examining problems in the supply chain – and what to learn from them.

3. How to deal with suspected and confirmed falsified Medicines

What is a suspected falsified medicine
How to identify falsified medicine in your workplace
How to approach the investigation of a suspected pack
What should the end user do with the pack – who should manage communication with the end users

You will be able to attend TWO of these workshops. Please choose the ones you like to attend when you register.

Case Studies:
The Roche Quality Governance Model for Distribution to Direct Markets

Selection, implementation, operation and decommissioning of partners
Key Performance Indicators (KPIs)
Compliance score card

The Switch from Air-freight to Sea-Freight

Challenges and Benefits
Examples

From external to internal Solutions - Insourcing of Warehousing and Logistics

Implementation of own storage areas for minimum supply at the site
Container and transport vehicle purchasing (refrigerated, warm, hazardous)

2 parallel Workshops:

1. Master Data and Serialisation

Master Data for Serialisation
Alerts Handling
Exercises

2. Distribution of ATMPs

Challenges when dealing with ATMP
What information is needed to help service providers
Examples

You will be able to attend ONE of these workshops. Please choose the one you like to attend when you register.

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